Hysteroscopic sterilization using a micro-insert device: Results of a multicentre phase II study
Kerin, J.F.; Cooper, J.M.; Price, T.; Herendael, B.J.Van.; Cayuela-Font, E.; Cher, D.; Carignan, C.S.
Human Reproduction 18(6): 1223-1230
2003
ISSN/ISBN: 0268-1161 PMID: 12773450 DOI: 10.1016/s1074-3804(05)60179-xDocument Number: 249371
BACKGROUND: Unlike laparoscopic surgery for interval tubal sterilization, a hysteroscopic approach obviates surgical incision and requires only local anaesthesia or intravenous sedation. The safety, tolerability and efficacy of an hysteroscopically placed micro-insert device was evaluated. METHODS: A cohort of 227 previously fertile women participated in this prospective international multicentre trial. Micro-inserts were placed bilaterally into the proximal Fallopian tube lumens under hysteroscopic visualization in outpatient procedures. RESULTS: Successful bilateral micro-insert placement was achieved in 88% of women. The majority of women reported that intraprocedural pain was less than or equal to that expected, and 90% rated tolerance of the device placement procedure as good to excellent. Most women could be discharged in an ambulatory state within 1-2 h. Adverse events occurred in 7% of the women, but none was serious. Correct device placement was confirmed in 97% of cases at 3 months. Over 24 months follow-up, 98% of study participants rated their tolerance of the micro-insert as very good to excellent. After 6015 woman-months of exposure to intercourse, no pregnancies have been recorded. CONCLUSIONS: Hysteroscopic sterilization resulted in rapid patient recovery without unacceptable post-procedure pain, as well as high long-term patient tolerability, satisfaction and effective permanent contraception.